Quality Assurance Associate at Stryker

St Leonards, Victoria, Australia

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Working knowledge of regulatory frameworks and legislation in Australia and New Zealand
Experience analyzing and interpreting regulatory documentation
Strong time management and planning skills
Effective communication and stakeholder engagement abilities
Ability to build relationships across diverse teams
Receptive to feedback and committed to personal growth
Detail-oriented problem-solver with great attention to detail, curiosity, and strong ability to develop meaningful relationships quickly
Thrive in complex, layered environments, enjoy collaborative work, and have a knack for translating complex concepts into practical business processes
Proactive, analytical, and committed to continuous improvement
Preferred Experience
Prior experience in regulatory affairs or quality assurance
Experience in a regulated industry, ideally medical devices
Familiarity with Australian and international medical device regulations
Tertiary qualifications in science, engineering, or a related field

Responsibilities

Own and manage QMS processes in accordance with ISO 13485 and regulatory standards
Act as a key contact for quality issues across SSP and global teams
Represent Stryker in internal and external audits
Lead and support Change Control, Nonconformances (NCs), and Corrective and Preventive Actions (CAPAs)
Train and coach SSP personnel on quality processes and regulatory obligations
Maintain and update standard operating procedures and ensure compliant record keeping and documentation
Drive process improvement initiatives and stay informed on regulatory changes and educate

Skills

ISO 13485

QMS

CAPA

Change Control

Nonconformances

Audits

SOP

Regulatory Compliance

Process Improvement

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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